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Completed

NCT Number: NCT03271723

The 2015 Pelotas (Brazil) Birth Cohort Study

This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health.

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Key information

Conditions

Mother-Child Relations Behavior Breast Feeding Communication Feeding Behavior Female Urogenital Diseases and Pregnancy Complications Infant Development Medicine, Narrative Motor Activity Narration Narrative Medicine Obstetric Labor Complications Obstetric Labor, Premature Physical Activity Pregnancy Complications Pregnancy Related Premature Birth Preterm Birth Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Physical Education School

Pelotas, Rio Grande do Sul, 96055-630, Brazil

About this study

The Pelotas 2015 Birth cohort is the fourth birth cohort being established in Pelotas since 1982. Data is being collected with a focus on maintaining fidelity to the tools and instruments used in the previous cohorts with minimal adaptations when necessary. All children born in Pelotas during 2015 were included in the cohort, and the cohort has been followed four times, at birth, 3, 12 and 24 months (ongoing). In addition, an antenatal study identified and interviewed 73.8% of the mothers that subsequently delivered children that are now part of the cohort. The 4275 children included in the cohort are part of extensive assessments that include information on antenatal health and care, pregnancy health, gestational age, physical activity, sleep, health behaviours, socio-demographic characteristics, perinatal conditions, child anthropometry, delivery information, child mortality and morbidity, nutrition, growth, breastfeeding, neuro-cognitive development, access to health services, medicine use by both mother and child and genetic material. The cohort also nests 2 randomized clinical trials and a series of sub-studies. The data is starting to be analyzed and, among other findings, confirm the already alarming trends in surgical deliveries, amounting to 65.2% of all deliveries in 2015.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • live births
  • mothers living in urban area of the city
  • delivered during 2015

Exclusion criteria

  • stillbirths below 500g
  • mothers living outside Pelotas

Treatment and study plan

observational study

Other

No intervention

Primary outcomes

  1. Preterm birth

    Time frame: At birth

    Births before 37 weeks of pregnancy

Secondary outcomes

  1. Physical activity

    Time frame: Second trimester of pregnancy

    Physical activities performed during pregnancy

Sponsors and collaborators

Lead sponsor

Federal University of Pelotas

Other

Collaborators

  • Wellcome Trust

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2015
First posted
Sep 5, 2017
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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